ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls— 510(k) K243575

Name: FDA 510(k) clearance K243575
Creator: U.S. Food and Drug Administration
Published: 2025-02-12

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K243575 for ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls, Substantially Equivalent on 2025-02-12. Applicant: Biokit, S.A.. Device class: 2.

Clearance details

Applicant: Biokit, S.A.
Product code: Code MYF
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2024-11-19
Decision date: 2025-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lliçà DAmunt, Barcelona, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code MYF

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K220924 — Elecsys HSV-2 IgG (08948887160)2022-10-12
K181514 — SeraQuest HSV Type 2 Specific IgG2019-06-13
K181334 — ADVIA Centaur Herpes-2 IgG2018-08-23
K152353 — SeraQuest HSV Type 2 Specific IgG2016-05-13
K103603 — ZEUS ELISA HSV GG-2 IGG TEST SYSTEM2011-05-20

More clearances from Biokit, S.A.

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K233605 — ADVIA Centaur EBV-EBNA IgG2024-08-07
K233606 — ADVIA Centaur EBV-VCA IgM2024-08-07
K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls2023-09-20
K214068 — Quantia IgE2023-02-21
K181333 — ADVIA Centaur Herpes-1 IgG2018-08-23

Adverse events under product code MYF

product code MYF

Injury: 316
Other: 1
Total: 317

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.